(類風濕性關節炎) 永昕LusiNEX 臨床一期 vs羅氏Actemra (IL-6 receptor antagonist) 至少5個三期臨床涵蓋5800人

永昕生物 發言日期 107/12/21 發言時間 06:31:34 發言人 溫國蘭 發言人職稱 總經理 發言人電話 037586988 主旨 公告本公司研發中生物相似藥LusiNEX第一期臨床試驗數據 解盲，主要試驗療效指標皆達統計生體相等性。 符合條款 第53款 事實發生日 107/12/21 說明 1.事實發生日:107/12/21 2.公司名稱:永昕生物醫藥股份有限公司 3.與公司關係(請輸入本公司或子公司):本公司 4.相互持股比例:不適用 5.發生緣由: (1)公告本公司研發中生物相似藥LusiNEX第一期臨床試驗數據解盲。(2)Title of Study: Phase I, Double-Blind, Randomized, Three-Arm, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab(EU and US). 中文試驗名稱：「一項第一期、雙盲、隨機、三項組別、平行的 藥物動力學、安全性及耐受性試驗，評估LusiNEX及Tocilizumab 在健康受試者上的生物相等性」。6.因應措施:無。7.其他應敘明事項: 一、研發新藥名稱或代號：LusiNEX 二、用途：治療類風濕性關節炎 三、預計進行之所有研發階段：人體臨床試驗審查（IND）；第一期臨床試驗(PhaseI/PK);第三期臨床試驗(PhaseIII)、藥品查驗登記審核(NDA)。四、目前進行中之研發階段：(一)提出申請／通過核准／不通過核准／各期人體臨床試驗 (含期中分析)結果：完成第一期臨床試驗數據解盲。根據解盲數據結果顯示，LusiNEX與羅氏大藥廠(Roche)在美國、歐洲及日本生產的Actemra對照組相比，在人體內的藥物動力學、安全性及耐受性試驗主要試驗療效指標 (Primary endpoint)皆達到生體相等性。(二)未通過目的事業主管機關許可或各期人體臨床試驗 (含期中分析)結果未達統計上顯著意義者，公司所面臨 之風險及因應措施：不適用。(三)已通過目的事業主管機關許可或各期人體臨床試驗 (含期中分析)結果達統計上顯著意義者，未來經營方向：LusiNEX之第三期臨床多國多中心試驗規劃中，且正與多家國際公司洽談授權合作及產品共同開發。(四)已投入之累積研發費用：因涉及未來LusiNEX國際授權談判資訊，恐影響授權金額，為保障公司及投資人權益，故不予公開揭露。五、將再進行之下一研發階段：(一)預計完成時間：2019年第一季向歐盟法規單位 (European Medicines Agency, EMA)及日本法規單位 (Pharmaceuticals and Medical Devices Agency)諮詢討論臨床三期試驗計畫內容。(二)預計應負擔之義務：不適用。六、市場現況：LusiNEX的原廠藥為Actemra，根據羅氏大藥廠 (Roche)2016年年報資料，全球市場銷售額約16.97億瑞士法郎 (約17.95億美元)。七、新藥開發時程長、投入經費高且並未保證一定能成功，此等可能使投資面臨風險，投資人應審慎判斷謹慎投資。

About Actemra Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA) and for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.